MEDICATION GUIDE

SIRTURO (ser toor oh)

(bedaquiline)
Tablets, for oral use
Read this Medication Guide before you start taking SIRTURO and each time you get a refill. There may be new information. This
information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about SIRTURO?
SIRTURO is an antibiotic prescription medicine used to treat multi-drug resistant tuberculosis (TB) of the lungs in people with
limited treatment options. Multi-drug resistant tuberculosis is a serious disease that can result in death and for which there are
few treatment choices. More people treated with SIRTURO cleared TB from their sputum compared to people who did not receive
SIRTURO.
It is important to complete the full course of treatment with SIRTURO and your other TB medicines and not skip doses. Skipping
doses may decrease the effectiveness of the treatment and increase the likelihood that your TB disease will not be treatable by
SIRTURO or other medicines.
SIRTURO can cause serious side effects, including:
In one clinical trial, more deaths were seen in people who were treated with SIRTURO compared to people who did not receive
SIRTURO.
Heart rhythm problems can happen with SIRTURO.
Talk with your healthcare provider about whether SIRTURO is right for you.
What is SIRTURO?
SIRTURO is an antibiotic prescription medicine used to treat resistant tuberculosis (TB) of the lungs.
It is not known if SIRTURO is safe and effective in:
people who do not have active TB
people who have TB that is not resistant to antibiotics
people who have types of TB other than TB of the lungs
people who have an infection caused by a bacteria other than TB
children under 18 years of age
Before you take SIRTURO, tell your healthcare provider if you:
have had an abnormal heart rhythm (ECG) or other heart problems.
anyone in your family has or has had a heart problem called congenital long QT syndrome.
have decreased thyroid gland function (this can be seen in a blood test).
have liver or kidney problems or any other medical conditions, including HIV infection.
are pregnant or plan to become pregnant. It is not known if SIRTURO will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SIRTURO passes into breast milk. You and your healthcare provider
should decide if you will take SIRTURO or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and
herbal supplements.
How should I take SIRTURO?
SIRTURO must always be taken with other medicines to treat TB. Your healthcare provider will decide which other medicines
you should take with SIRTURO.
Take SIRTURO with food. Swallow the tablets whole with water.
Take SIRTURO exactly as your healthcare provider tells you to take it. Take SIRTURO for a total of 24 weeks. You may need to
take your other TB medicines for longer than 24 weeks. Check with your healthcare provider.
Week 1 and Week 2:
Take 400 mg (4 tablets) 1 time each day.
Week 3 to Week 24:
Take 200 mg (2 tablets) a day 3 times a week.
T ake SIRTURO doses at least 48 hours apart. For example, you may take SIRTURO on Monday, Wednesday and Friday every
week.
D
 o not skip SIRTURO doses. If you skip doses, or do not complete the total 24 weeks of SIRTURO your treatment may not work
as well and your TB may be harder to treat.
If you take more SIRTURO than you should, talk to a healthcare provider right away.

SIRTURO (bedaquiline) tablets, for oral use

How should I take SIRTURO? (continued)

If you miss your SIRTURO dose during Week 1 or Week 2:
Do not take a double dose to make up for the missed dose. Take the next dose as usual.
If you miss your SIRTURO dose during Week 3 to Week 24:
Take the missed dose as soon as possible and resume the 3 times a week schedule.
If you miss a dose and you are not sure what to do, talk to your healthcare provider.
Do not stop taking SIRTURO without first talking to your healthcare provider.
What should I avoid while taking SIRTURO?
You should not drink alcohol while taking SIRTURO.
What are the possible side effects of SIRTURO?
SIRTURO may cause serious side effects, including:
See What is the most important information I should know about SIRTURO?
s erious heart rhythm changes (QT prolongation). Tell your healthcare provider right away if you have a change in your heartbeat
(a fast or irregular heartbeat), or if you faint.
l iver problems (hepatotoxicity). Call your healthcare provider right away if you have unexplained symptoms such as nausea or
vomiting, stomach pain, fever, weakness, itching, unusual tiredness, loss of appetite, light colored bowel movements, dark colored
urine, yellowing of your skin or the white of your eyes.
The most common side effects of SIRTURO include nausea, joint pain, headache, an abnormal lab test associated with damage to
the pancreas, coughing up blood, chest pain, loss of appetite, or rash.
These are not all the possible side effects of SIRTURO. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SIRTURO?
Store SIRTURO at 59F to 86F (15C to 30C).
Keep SIRTURO in the original container, and keep SIRTURO out of light.
Keep SIRTURO and all medicines out of reach of children.
General information about the safe and effective use of SIRTURO:
This Medication Guide summarizes the most important information about SIRTURO. If you would like more information, talk to your
healthcare provider. You can ask your pharmacist or healthcare provider for information about SIRTURO that is written for health
professionals.
What are the ingredients in SIRTURO?
Active ingredient: bedaquiline
Inactive ingredients: colloidal anhydrous silica, corn starch, croscarmellose sodium, hypromellose 2910, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing)
Product of India
Finished Product Manufactured by: Kemwell Biopharma Pvt. Ltd., Bangalore, India
Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP Titusville, NJ 08560
Janssen Products, LP 2012
This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised: 12/2015
040967-160105